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Best Medical International
BEST MEDICAL INTERNATIONAL, INC. · Model 784-5 · UDI-DI 00841365100697
1
510(k) clearances
606
Adverse events (41 deaths)
7
Recalls
33
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-10 | Bard Brachytherapy, Inc. | Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose in Vial with Steril |
| 2016-12-09 | C.R. Bard, Inc. | Activity and quantity of seeds sent in shipments were incorrect. |
| 2012-01-25 | Varian Medical Systems, Inc. | Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment. |
| 2011-09-20 | Medi-Physics Inc. dba GE Healthcare | There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy. |
| 2008-03-03 | Source Production & Equipment Inc | Radioactive source broke during use. |
| 2005-05-16 | Theragenics Corporation | The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date. |
| 2005-05-03 | Manan Medical Products, Inc. | The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.